Compliance Review for Medical Device Manufacturer
How does a medical device manufacturer successfully respond to an FDA inspection observation? Conduct a site-wide review and open a CAPA plan to document actions, findings, and results.
Discover how Oxford’s team quickly helped capture and address issues to achieve full compliance.
CQV for a Medical Device Manufacturer
What does it take for a medical device manufacturer to successfully transition from manual production to automation? Custom-designed specifications to build, install, qualify, and validate new equipment.
Discover how Oxford’s team helped create an FDA-compliant automated production process.
FDA Inspection Prep for Hearing Aid Maker
What does it take for a hearing aid & accessories manufacturer to successfully prepare for an FDA inspection? Launch an inspection readiness project to implement compliance standards into documents, systems, and processes.
Discover how Oxford promptly provided 15 consultants that were critical to achieving an observation-free site inspection.
FDA Remediation for Cardiovascular Device Maker
When a cardiovascular medical device manufacturer receives an FDA Warning Letter, how do they successfully respond to the issue? Launch a task force to remediate technical documentation, processes, and systems.
Discover how Oxford’s consultants helped to remediate the issue and pass the FDA re-inspection.
CQV for Biotechnology Facility Expansion
How does a biotechnology manufacturer successfully expand their facility on a short timeframe with limited resources? Bring in experts to ensure all commissioning, qualification, and validation services are accurately performed on time.
Discover how Oxford’s talent helped meet the deadline and complete the facility expansion.
Remediation for FDA Readiness
When a global medical manufacturer needs to pass an upcoming FDA inspection, how do they prepare? By engaging an experienced team of professionals, customized to identify the specific improvements needed to achieve compliance.
Discover how Oxford consultants revised a Quality Management System to meet FDA regulations within 7 weeks.
Compliance for Combination Products
What does it take for a large medical device manufacturer to successfully achieve compliance for a new range of combination products? A team of senior-level consultants with expert knowledge of medical devices and pharmaceuticals.
Discover how Oxford helped our client qualify 50 combination products in 3 years.
Gap Assessment and Workstreams for MDR Compliance
In order to achieve MDR compliance within the provided deadlines, how does a medical device manufacturer achieve their goals while also maintaining day-to-day operations? With support and partnership from experts who understand the nuances of such a complex project.
Discover how Oxford provided assistance to keep the project on track.